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Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice

NCT03945383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-10-19

No results posted yet for this study

Summary

Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy women of skin types I up to and including V.

Safety and efficacy of hair removal with the Emerald IPL-device will be investigated for treatment in face of subjects with ST I - IV and for treatment in face, axilla, bikini area, and legs of subjects with ST V.

In-clinic, the study subjects will undergo twelve IPL-treatments bilaterally at the qualified areas (face and / or axilla, bikini line, and legs) with the Emerald IPL device applied by a device operator.

Hair re-growth in each area will be evaluated separately and across all skin types.

After the 4 bi-weekly treatments, one follow-up visit will be organized two weeks after the 4th treatment. After the completion of the full treatment cycle (12 treatments), subjects will be followed for 1 and 3 months (short-term follow-up) and for 6, 9 and 12 months (long-term follow up).

Conditions

  • Hair Removal

Interventions

DEVICE

Treatment with IPL device

Treatment with IPL device

Sponsors & Collaborators

  • Philips Healthcare

    lead INDUSTRY

Principal Investigators

  • Rupal Trivedi, M.D. · Great Lakes Clinical Trials

  • David Pariser, M.D. · Virginia Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2022-01-14
Completion
2022-01-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945383 on ClinicalTrials.gov